ANDA 209119

ALEMBIC PHARMS LTD

FDA Drug Application

Application #209119

Application Sponsors

ANDA 209119

ALEMBIC PHARMS LTD

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

32MG

0

CANDESARTAN CILEXETIL

CANDESARTAN CILEXETIL

FDA Submissions

UNKNOWN;	ORIG	1	AP	2017-06-20	STANDARD
LABELING; Labeling	SUPPL	7	AP	2021-03-08	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	7	Null	7

TE Codes

001

Prescription

AB

CDER Filings

ALEMBIC PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209119
            [companyName] => ALEMBIC PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"CANDESARTAN CILEXETIL","activeIngredients":"CANDESARTAN CILEXETIL","strength":"32MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/20\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-06-20
        )

)